FDA.reportPublic FDA data

Lip Conditioner SPF 15

Product NDC
57627-107
11-digit product format
576270107
Labeler code
57627
Product ID
57627-107_5da96cd0-e136-c28f-e063-6394a90a9132
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE,OCTISALATE
Dosage form
JELLY
Route
TOPICAL
Labeler
Merle Norman Cosmetics, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-21
Substance
OCTINOXATE; OCTISALATE
Active strength
.278; .185 g/3.7g; g/3.7g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Lip Conditioner SPF 15
Brand name suffix
Merle Norman
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE.278 g/3.7g
OCTISALATE.185 g/3.7g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-107-01Lip Conditioner SPF 15Merle Norman3.7 g in 1 TUBEJELLY3.719
57627-107-02Lip Conditioner SPF 15Merle Norman1 in 1 CARTONJELLY119

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
OCTISALATEACTIVE INGREDIENT4X49Y0596WLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
OCTINOXATEACTIVE MOIETY4Y5P7MUD51LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
OCTISALATEACTIVE MOIETY4X49Y0596WLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
ASTROCARYUM MURUMURU SEED BUTTERINACTIVE INGREDIENT12V64UPU6RLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
CERESININACTIVE INGREDIENTQ1LS2UJO3ALIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
ELAEIS GUINEENSIS FRUIT BUTTERINACTIVE INGREDIENTUYH3R74N56LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
HELIANTHUS ANNUUS SEED WAXINACTIVE INGREDIENT42DG15CHXVLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
MACADAMIA OILINACTIVE INGREDIENT515610SU8CLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-107LIP CONDITIONER SPF 15 MERLE NORMAN (OCTINOXATE,OCTISALATE) JELLY [MERLE NORMAN]18Current NDC, Legacy NDC, 2 package rows20241004_b28459dc-c2df-4f8b-8b37-0090e223e6e9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 12 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Juice Body Mist Sunscreen SPF30 - Cotton Candy Skies PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC568083ff-0da9-7f14-e063-6394a90a43012026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Vanilla Breeze PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc62c97-70c5-17f7-e063-6394a90abe252026-07-13WarningsExact identifier
application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 RoseZINC OXIDENorwex Usa, Inc.565feded-8e25-e628-e063-6294a90aee482026-07-11WarningsExact identifier
application number: M020
PoutScreen Lip Treatment Lemon MeringueAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD563e3ab9-4ee2-279c-e063-6294a90a7cf12026-07-10WarningsExact identifier
application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWNZINC OXIDECOSMAX USA, CORPORATION5643a73d-757c-702d-e063-6294a90a2c122026-07-10WarningsExact identifier
application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - LATTEZINC OXIDECOSMAX USA, CORPORATION5643d655-e335-5643-e063-6394a90a483a2026-07-10WarningsExact identifier
application number: M020
MUSELY DAYCREAM SPF40ZINC OXIDECOSMAX USA, CORPORATION56443156-3edb-a643-e063-6394a90adf9f2026-07-10WarningsExact identifier
application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40ZINC OXIDECosmax USA, Corporation56445f2d-8e5a-34eb-e063-6294a90ae26e2026-07-10WarningsExact identifier
application number: M020
Hello Kitty Fun Broad Spectrum SPF 40ZINC OXIDECosmax USA Corporation5644854e-18d6-617d-e063-6294a90ab3e72026-07-10WarningsExact identifier
application number: M020
VERSED DAILY SUNSCREEN SPF 50HOMOSALATE, OCTISALATE, AVOBENZONECOSMAX USA, CORP5644ca1e-9032-d3fb-e063-6394a90a961e2026-07-10WarningsExact identifier
application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40ZINC OXIDECosmax USA Corporation5644855d-f864-e07b-e063-6394a90a51482026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40ZINC OXIDECOSMAX USA, CORP5644d49f-08b9-e806-e063-6294a90a80f92026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT NEUTRALZINC OXIDECOSMAX USA, CORP564682e5-1051-9936-e063-6394a90abe1d2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT WRMZINC OXIDECOSMAX USA, CORP5646e069-5461-12c5-e063-6294a90abacb2026-07-10WarningsExact identifier
application number: M020
Protect Sport SunscreenBROAD SPECTRUM SPF 30Opal Day Spa564704f2-b26a-d737-e063-6294a90aa6ff2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM NEUTRALZINC OXIDECOSMAX USA, CORP5647162a-610e-2789-e063-6294a90a75492026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM OLIVEZINC OXIDECOSMAX USA, CORP56472adb-572d-5a52-e063-6294a90a3cc32026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM COOLZINC OXIDECOSMAX USA, CORP56474782-beff-8437-e063-6294a90a83222026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM PEACHZINC OXIDECOSMAX USA, CORP564749f3-e820-9003-e063-6294a90a02652026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRALZINC OXIDECOSMAX USA, CORP56477f58-3878-81fa-e063-6294a90a87b72026-07-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-107-01576270107013.7 g in 1 TUBE3.7 gHistorical
57627-107-02576270107021 TUBE in 1 CARTON (57627-107-02) / 3.7 g in 1 TUBE (57627-107-01) 1 tube2011-04-210000-00-00NoNoCurrent